CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 88 enrolled
Drug / intervention
1% Lidocaine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02288364
NCT02288364Phase 4Completed

Does Sodium Bicarbonate Reduce the Pain of Lidocaine for Local Anesthesia in Percutaneous Breast Biopsies?

Duke University·interventional·Posted Nov 11, 2014·Updated Apr 15, 2016

In Brief

A Phase 4 clinical trial evaluating 1% Lidocaine and 1% Lidocaine plus sodium bicarbonate for Pain of Anesthesia at Breast Biopsy. Completed, enrolled 88 participants across 1 site.

Detailed Summary

The purpose of this study is to determine the benefit, if any, of buffering lidocaine (adding sodium bicarbonate) when used for local anesthesia prior to percutaneous breast needle core biopsies. The medicine doctors use to reduce the pain of breast biopsies, lidocaine, can cause pain for approximately 15 seconds until the numbing effect begins. It is possible that this pain is caused because lidocaine is acidic. Some physicians believe that reducing the acidity of lidocaine by mixing it with sodium bicarbonate will reduce the initial pain of injecting the lidocaine. Both approaches - injecting 1% lidocaine alone and injecting 1% lidocaine mixed with sodium bicarbonate - are used as routine standard of care by radiologists today. The purpose of this study is to determine if either approach is more comfortable for patients having breast procedures.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 11, 2014
Enrollment StartDec 1, 2014
Primary CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 11.6 years ago

Interventions

1% Lidocainedrug

1% Lidocaine plus sodium bicarbonatedrug